Mobile front-end system for comprehensive cardiac diagnosis

ABSTRACT

A stethoscope front-end recorder device (also referred to as Sleeve) for the chest piece of a stethoscope, which is easily installed and removed. The Sleeve is attached to the chest piece of a stethoscope for comprehensive diagnosis of heart issues. The Sleeve contains sensors for acquiring biosensor parameters such as electrocardiogram, body temperature, heartbeat, heart rhythm, heart rate variability, heart rate turbulence, heart sounds, respiration, cardiac index and blood flow. The Sleeve has Bluetooth interface communicating with a mobile device with software component, interfacing with a back-end server with the capability to capture, analyze and save patient information.

BACKGROUND OF THE PRIOR ART

The heart and body produce hundreds of specific sounds, including heart,lung, bowel, circulatory and Korotkoff sounds. These sounds andcombinations thereof are indicative of normal and abnormal conditions.Knowledge of these sounds provides valuable diagnostic information tothe physician. The art of listening to these sounds and using them asdiagnostic aids is known as auscultation. Early human beings have beenable to listen to these sounds by placing the ear to the chest or backof the patient. Later, the air column stethoscope was developed. Thestethoscope has proven to be a valuable instrument for medicalprofessionals. The standard air column stethoscope used by the medicalprofession employs a listening cup placed on the chest or back of thepatient with the sound amplified by a simple bell and diaphragm into astanding air column terminating in earpieces for the physician's ears.

The conventional stethoscope has remained relatively unchanged since thelast century. Many problems exist with the use of conventionalstethoscopes. In general, conventional stethoscopes offer verysubjective information. For example, the hearing capability of the userhas direct impact on the sounds observed. When a loud sound is followedby a soft sound, difficulty exists in detecting and assessing theintensity of the soft sound. It is difficult to time an abnormal heartsound with respect to the phase of the heartbeat, an important aspect ofmurmur diagnosis. A fast beating heart can make both the recognition andtiming of abnormal sounds difficult. This problem is often found withchildren and animals where heart rates are often much higher than inadult humans. External noise may often mask heart, lung, circulatory andKorotkoff sounds detected under non-ideal listening conditions. Theseand many other problems plague the conventional stethoscope.

In response, the field has developed electronic stethoscopes that detectand display as waveforms both audio (heart sound) and ECG (heartelectrical activity), as well as presenting the heart sounds aurally.Little et al. (U.S. Pat. No. 4,362,164) describe a stethoscope having adetector head that includes a microphone and is selectably connectableto either a conventional chest-bell or an electrode chest-bell. Theelectrode chest-bell is adapted to pick-up electric heart signals, andthe microphone to pick up body sounds. The electrode and microphonesignals are sent to a separate monitoring unit to display both ECG andphonocardiographic waveforms. The conventionally detected body soundsare transmitted via air column tube directly to the user's ears.However, the Little device, and others like it, require connectivity(either via interconnect cable of wireless transmission) between thestethoscope and a separate display unit, and they are not easilytransported about a physician's or other care staffs person. Again,although these devices also may be useful for their intended purpose,they too have their limitations.

Most efforts at visual display of heart data have been directed to theelectrocardiographic wave pattern. Because the electrocardiographic wavepattern, i.e., the electrical wave pattern generated by the heart, ismore easily processed and displayed, the electronic monitoring,displaying and storing of the electrocardiographic wave pattern has beenaddressed. Many patents deal with the detection, storage and display ofthe electrocardiographic wave pattern. Early efforts to visually displayheart data were disclosed by Vogelman in U.S. Pat. No. 3,921,624.Shimoni in U.S. Pat. No. 4,617,938 and Citron in U.S. Pat. No. 4,417,306disclosed systems for acquiring and recording electrocardiographic wavepatterns. Further, Lisiecki disclosed a transfer of the recorded signalsto a fixed computer for visual display. Anderson in U.S. Pat. No.4,628,327 disclosed the acquisition, digitalization and storage ofelectrocardiographic wave patterns in a circular memory. Upon trippingof an alarm indicating a preset abnormal condition, the attachedrecorder rapidly produces a visual output of the stored data both beforeand after the event which tripped the alarm. Yoneda in U.S. Pat. No.4,779,199 similarly disclosed acquisition and digitalization of theelectrocardiographic wave pattern. Further, U.S. Pat. No. 4,115,864 andU.S. Pat. No. R 29,921 both disclosed the acquisition and storage ofelectrocardiographic wave pattern data followed by a display of thatdata with previously recorded electro cardiographic wave patterns topermit a visual comparison of the results by the physician.

As the above patents illustrate, most efforts at electronic storage anddisplay of heart data have been directed to the electrocardiographicwave pattern. This is because the ECG wave pattern is much simpler andat a significantly lower frequency than the phonocardiographic heartsounds. Detection, digitization, storage and display of thephonocardiographic heart sounds are complicated by the presence of manyother body sounds and by their higher frequency and more variable wavepattern. However, some work has been done in this area. Slavin in U.S.Pat. No. 4,483,346 disclosed a portable device for recording both anelectrocardiographic wave pattern and phonocardiographic sounds. Thephonocardiographic sounds were digitalized and stored for latertransmission through a modem to a computer for storage and display. InU.S. Pat. No. 4,624,263, Slavin added cassette storage capability to thepreviously disclosed portable recorder. Further, Slavin disclosed thestorage of abnormal phonocardiographic information for displaying withthe patient's heart sounds to illustrate differences.

Although these devices may be useful for their intended purposes and mayovercome some of the limitations of the classic air column stethoscope'sdependence on the inherent energy contained in the original body sound,they do not address the issue that aural auscultation alone may not besufficient to perform an adequate diagnosis, particularly of heartcondition and are integrated into the chest piece or converting theconventional stethoscope into an electronic stethoscope.

Heart Failure—Congestive heart failure (CHF) is defined as impairment ofsystolic and/or diastolic function of the heart, leading to failure tomeet the demands of peripheral tissues, or leading to maintenance ofcardiac function under higher filling pressures.

In other words, CHF is a complex clinical entity that is characterizedby ventricular dysfunction and compensatory neuron-hormonal alterationaccompanied by exercise intolerance, fluid retention, and decreased lifeexpectancy.

In CHF, the renin-angiotensin-aldosterone system and the sympatheticnervous system are considered to be of the utmost importance. These 2interrelated systems regulate vascular tonus, heart rate, andcontractility. CHF may stem from diastolic or systolic dysfunction.

In general, the 5-y mortality rate has been around 75% for men and 65%for women with CHF, whereas the 1-y mortality rate for severe andmoderate forms of the disease reaches 40% to 50% and 15% to 25%,respectively. Coexistence of systolic and diastolic dysfunction is afrequent finding in CHF. Systolic dysfunction, in particular, isconsidered to be much more important in predicting the morbidity andmortality rates of the disease.

Echocardiographic evaluation of left ventricular ejection fraction(LVEF) obtained via the Simpson method has been an important parameterin the evaluation of systolic function, whereas atria-ventriculardiastolic inflow waves have been obtained to assess diastolic functionof the heart. Myocardial performance index (MPI) (Tei index) has beenregarded as an important parameter in the evaluation of ventricularsystolic function in congestive heart failure. MPI is defined as the sumof isovolumic relaxation time (IVRT) and isovolumic contraction time(IVCT) divided by left ventricular ejection time (LVET)([IVRT+IVCT]/LVET). MPI is a Doppler-derived time interval index thatcombines both systolic and diastolic cardiac performance. The Tei indexhas been difficult to derive by using conventional non-Doppler pulsedechocardiography.

Therefore, it would be beneficial to have a versatile accessory to theconventional stethoscope that is easily portable, and has the capabilityto monitor and display at least heart sounds and heart electricalactivity, as well as preserving the usual auscultation purposes of theconventional stethoscope that aids clinicians in diagnosingcomprehensive heart issues.

BRIEF SUMMARY OF THE INVENTION

The present invention is the provision of a stethoscope front-endrecorder device (also referred to as Sleeve) for the chest piece of astethoscope, which is easily installed and removed. The Sleeve coversthe circumference of the chest piece of a stethoscope. The Sleevecontains sensors for acquiring biosensor parameters such aselectrocardiogram (ECG), body temperature, heartbeat, heart rhythm,heart rate variability (HRV), heart rate turbulence (HRT), heart sounds,respiration, heart murmur, heart rhythm, heart failure and blood flow.The Sleeve sensor system may be self-contained and does not requireancillary equipment to be connected or linked to the stethoscope toaccomplish its utility.

In one embodiment, the current invention includes A method ofdetermining an acoustic and electrical footprint of the heartcomprising: (1) acquiring heart sounds and electrocardiogram, (2)transmitting the heart sound and the electrocardiogram to an acousticstethoscope, (3) wirelessly transmitting the heart sound and theelectrocardiogram to a mobile device, using a processor and wirelessmodule, (4) the mobile device transmitting the heart sound and theelectrocardiogram to a remote server, wherein the remote server analyzesboth the heart sound and the electrocardiogram and determines cardiacmalfunction, (5) transmitting the results to the mobile device andarchiving the results after transmission, and (5) displaying on themobile device the result of the analysis.

The current invention includes a system for determining normal andpathological heart sound comprising: (a) stethoscope front-end recorderdevice with biological sensors, wherein the front-end recorder device isconfigured to (a) acquire at least body sounds and electrocardiogramsignals, (b) transmitting the at least body sounds and electrocardiogramsignals to a client device and (c) display data transmission and batterylife status.

The invention includes a client device configured to: display at leastbody sounds and electrocardiogram, enable a user to create or selectpatients, enable the user to select body sound location andelectrocardiogram leads, record and review body sounds,electrocardiogram and cardiac index, transmit body sound andelectrocardiogram signals to a remote server.

The invention includes remote server configured to: (1) analyze bodysound and electrocardiogram for normal and pathological conditions, (2)authenticate the user, (3) archive body sounds, electrocardiogram andcardiac index.

One aspect of the invention is to provide a mobile system that monitorsthe electrical conductivity and the mechanical function of the heart foranalyzing the entire cardiac cycle, wherein a user can track electricaldeficiencies of the heart along with any abnormalities of the cardiaccycle, thereby detecting heart failure.

Another aspect of the invention is to provide a mobile system thatmonitors the cardiac cycle by analyzing the electrical conductivity andmechanical functions of the heart for heart rate. The mobile systemmeasures the isovolumic contraction time (IVCT), isovolumic relaxationtime (IVRT) and ejection time (ET), wherein a user abnormalities to thecardiac cycle that may be surrogate to heart failure and ejectionfraction.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following description embodiments of the object according to theinvention is described with the help of the attached drawings.

FIG. 1 illustrates a block diagram of the system and its components

FIG. 2 illustrates the bottom view of the Sleeve

FIG. 3 illustrates a top view of the Sleeve

FIG. 4 illustrates a cross section of the Sleeve

FIG. 5 illustrates a block diagram of the electrical components

FIG. 5A Illustrates an interaction between a self-contained Sleeve,Mobile device and server

FIG. 6 Illustrates Server, Network, Client Devices and Sleeveinteraction

FIG. 7 illustrates how the devices are connected to each other

FIG. 8 illustrates a mobile client device

FIG. 9 illustrates a block diagram of the mobile client device

FIG. 10 illustrates a new session creation

FIG. 11 illustrates a recording session

FIG. 12 illustrates viewing of recorded results

FIG. 13 illustrates the creation of new patients

FIG. 14 illustrates an alternative ring Sleeve

FIG. 15 illustrates the alternative ring Sleeve with Sensors

FIG. 16 illustrates the alternative ring Sleeve with alternativeenclosure box

FIG. 17 shows an algorithm of acquiring systolic performance index.

FIG. 18 shows a depiction of the cardiac cycle.

FIG. 19 shows a wall mounted integrated point of care diagnostic system.

DETAILED DESCRIPTION

The inventive system, in accordance to FIG. 1, consists of a stethoscopefront-end recorder device 100 (also referred to as stethoscope recorderdevice or Sleeve) with a Bluetooth interface 105 connected to a standardacoustic stethoscope 104, a mobile device 106 with software componentrunning on it, interfacing the stethoscope recorder device and aback-end server 113, with the capability to capture and save patientinformation to the backend server 113, as well as receiving analysisresults and accessing stored patient information from the back-endserver 113. A data processing unit on a back-end server 113 analyzes 109the heart sound and ECG signal for pathological murmurs or onlyrecording the ECG signal. The backend server 113 contains an encrypteddatabase 108 for storing patient information. It also contains aweb-server 112 and interface 115 for a user(s) to securely accesspatient data.

The sleeve interfaces with an acoustic stethoscope 114 and records boththe acoustic heart sound 102 and/or ECG signals 101. In a preferredembodiment, those signals are sent via Bluetooth wireless communicationprotocol 105 to a mobile device 106. The sleeve can also communicatewith the mobile device via wireless local area network (WLAN) productsthat are based on the Institute of Electrical and Electronics Engineers'(IEEE) 802.11 standards such as Wi-Fi. It can also use cellular networkor mobile network. When the device's integral electrodes are placed onthe chest of the patient, it is capable of verifying, measuring, storingand transmitting to a database the cardiac bio-potential activity.

By using a cellular telephone or other client devices on whichcustomized Sleeve software is installed to review physiologic data of apatient and to (a) view the near real-time waveforms remotely (b)remotely review other standard patient data. The Sleeve software candisplay at least the following physiologic data captured by thefront-end recorder device:

a) ECG Waveform

b) Auscultation Waveform

c) Cardiac Index

d) Systolic Blood Pressure Cuff

e) Diastolic Blood Pressure Cuff

Referring to FIG. 3, the sleeve 300 covers the circumference or theouter edge of a conventional stethoscope 301 applied to the diaphragm ofstethoscope 405 of FIG. 4. The sleeve 300 is held in place on the chestpiece of the stethoscope by a flexible, stretchable skirt 305 extendingto the edge the circumference of the stethoscope's bell 301. The sleevehas a thickness of at least 0.5 inch. The circumference of the sleevecontains at least 2 ECG electrodes obtaining 202A and 202B of FIG. 2signals and a diaphragm 201. The ECG electrodes enable the user recordECG Lead I, Lead II and Lead III, by rotating the negative and positiveelectrodes around the patient's chest, using einthoven's triangle vectortheory, similar to what taught in U.S. Pat. No. 6,884,218 (incorporatedby reference).

Referring to FIG. 4, the sleeve 400 contains printed circuit board, orPCB 404 and an optional display module (not shown) in an enclosure box400. The PCB 404 contains electronics circuitry that comprises aprocessor 403 and the corresponding circuitries for biosensor parameters501 of FIG. 5. Referring to FIG. 5, the PCB contains a computerprocessing unit (CPU) 502 with memory 503, an input/output (I/O) circuit510, and an optional view screen 504. A power supply 506 is in operativecommunication with the circuits of the display and processing modules toprovide electrical power as needed. The electric signal inputs from tothe sensors (e.g., ECG, temperature, and microphone) are inputted viathe electrode connector of the sensor sleeve. The sensor circuitriesfurther condition and digitize the biosensors parameters from the sensorsleeve. The digitized signals are then conducted under the control ofthe CPU and memory circuits to the view screen display for visualdisplay, or to the I/O and communication ports for export from the PCDMto client devices (e.g., mobile, pc or remote server, printers, datastorage devices, signal display equipment and other devices). The Sleevecontains light-emitting diodes 304 of FIG. 3 (LEDs) as indicators tocommunicate different modes such as on/off, data transfer, and batteryindicator. The Sleeve also includes a power switch 303, andnegative/positive indicators 302A and 302B. The Sleeve also contains 2.5mm headphone port for output body sounds to headphone or speakers.Alternatively, the captured heart or body sound may be output to aspeaker or sound exciter, used to enhance the sound signal going tostethoscope.

In a preferred embodiment, the power supply is a rechargeable powersupply, and more particularly, a rechargeable battery 402 of FIG. 4power supply. In the preferred embodiment, the battery or batteries ofthe power supply is rechargeable lithium polymer battery.

The CPU processor comprises a tangible medium, for example read onlymemory (ROM), electrically erasable programmable read only memory(EEPROM) and/or random access memory (RAM). The processor may comprisemany known processors with real time clock and frequency generatorcircuitry, for example the PIC series of processors available fromMicrochip, of Chandler Ariz. In some embodiments, processor may comprisethe frequency generator and real time clock.

The processor can be configured to control a collection and transmissionof data from the ECG, microphone, accelerometer and temperaturecircuitries. In another embodiment, the processor may be configured tocollect data from a pressure transducer for nasal airflow. In otherembodiments, the processor may be configured to collect data from ablood pressure monitor, pulse oximeter, electromyogram (EMG), Dopplerand ultrasound.

The PCB 404 also comprises of wireless communication circuitry 511 ofFIG. 5, communication module coupled to the processor system to transmitthe biosensor parameters to client devices 508 (mobile or personalcomputer) or remote server 509 with a communication protocol 512. Thecommunication protocol may comprise at least one of Bluetooth, Zigbee,WiFi, WiMax, IR, a cellular protocol, amplitude modulation or frequencymodulation. The client devices may comprise a data collection, analysisand display systems to collect and/or store data from the wirelesstransmitter and wherein the data collection system is configured tocommunicate periodically with the remote center and the Sleeve withwireless connection and/or wired communication. In some embodiments, thesleeve sensor device may have a rechargeable module, and may use dualbattery and/or electronics modules, wherein one module can be rechargedusing a charging station while the other module may be a tiny USB portplaced on the sleeve sensor.

Referring to FIG. 5A, in another embodiment, the sensor sleeve A501 maybe self-contained unit affixed and/or adhered to the body of the patientor user. For example, the sensor sleeve may be affixed and/or adhered tothe body with at least one of the following: an adhesive tape,suspenders around shoulders, a pre-shaped electronics module to shapefabric to a thorax, a pinch onto roll of skin, or transcutaneousanchoring. The sleeve sensor may also adhere to the body via a cheststrap, and/or a low-irritation adhesive for sensitive skin. In additionto having a circular shape, the sensor device can be comprised of manyshapes, for example at least one of an hourglass, an oblong, a circularor an oval shape. The sleeve sensor may comprise a reusable electronicsFIG. 5 module with replaceable cover, and each of the replaceable coversmay include a battery. The sleeve sensor electronics may comprise of amodule for collecting biosensor data for approximately at least 1 day,with the capability to wirelessly send data to a client device viaBluetooth, Zigbee, WiFi, WiMax, IR, a cellular protocol, amplitudemodulation or frequency modulation or wired via Universal Serial Bus(USB) and proprietary connectors. The entire sleeve sensor andelectronics component may be disposable. In some embodiments, the sleevesensor device may have a rechargeable module, and may use dual batteryand/or electronics modules, wherein one module can be recharged using acharging station while the other module may be a tiny USB port placed onthe sleeve sensor.

The bottom of the sleeve contains a diaphragm 401 in FIG. 4. When thediaphragm is placed against the patient, the sounds of the body vibratethe plastic disk and acoustic pressure waves are formed. These pressurewaves travel up the sound chamber 401, delivering body sounds to thebottom of the user's stethoscope 405, which is attached to the lid ofthe sleeve 407.

Running on the backend server 113 is heart sound analysis software 109that assists medical examiners in analyzing cardiac sounds for theidentification and classification of suspected murmurs. It is used todistinguish between normal/physiological and pathological heart murmursby recording the acoustic signal of the heart and the ECG signalsimultaneously and analyze these signals. The acoustic heart signal isanalyzed to identify specific heart sounds that may be present.

FIG. 6 illustrates a block diagram of a generic computer server 309 thatmay be used according to an illustrative embodiment of the invention.The computer server 309 may have a processor 601 for controlling overalloperation of the server and its associated components, including RAM602, ROM 603, input/output module 604, and memory 605.

I/O 604 may include a microphone, keypad, touch screen, and/or stylusthrough which a user of device may provide input, and may also includeone or more of a speaker for providing audio output and a video displaydevice for providing textual, audiovisual and/or graphical output.Software may be stored within memory 605 and/or storage to provideinstructions to processor 604 for enabling server 609 to perform variousfunctions. For example, memory 605 may store software used by the server609, such as an operating system 606, application programs 607, and anassociated database 608. Alternatively, some or all of server 609computer executable instructions may be embodied in hardware or firmware(not shown). As described in detail below, the database 608 may providecentralized storage of account information and account holderinformation for the entire business, allowing interoperability betweendifferent elements of the business residing at different physicallocations.

According to certain aspects, the server 609 may operate in a networkedenvironment supporting connections to one or more remote devices, suchas client devices 616, 617, 618 (cell phone, PC, laptop and tablets) viathe internet 614, communicating with the Sleeve 615. The communicationnetwork in this example may be connected to an Internet router via aLocal Area Network (LAN) network 613 or Wide Area Network (WAN) 612, andmay receive electrical power via a supplied AC power adaptor.

Referring to FIGS. 8-9, the sleeve software application is installed ona mobile device 801. The software component running on a mobile device,interfaces with the stethoscope recorder device and the back-end server,with the capability to capture and save patient information to aback-end server, as well as receiving analysis results and accessingstored patient information from the back-end server.

In a preferred embodiment, the mobile device 801 interfaces viaBluetooth 105 with the sleeve device to capture the acoustic heart soundand/or ECG signals on a mobile device and manage this connection. Themobile device sequences the recording of the acoustic heart sound andECG signals at the various recording locations between the Sleevefront-end and mobile device.

FIG. 9 is a block diagram illustrating selected elements of the mobilecommunication device 900 in accordance with some embodiments. Aprocessor 908 is coupled to a wireless radio transceiver 902, a display906, a keypad 907, and a memory 905. The radio transceiver 901 isconnected to an antenna 902, which is an example of an antenna and isadapted to send outgoing voice and data signals and receive incomingvoice and data signals over a radio communication channel. The radiocommunication channel can be a digital radio communication channel(e.g., a cellular channel as provided by a cellular service provider),such as a CDMA or GSM channel such a radio communication channel has thecapacity to communicate both voice and data messages using conventionaltechniques. In some embodiments, the processor 908 also is coupled to asecond Wireless transceiver 901 (e.g., a Bluetooth or WiFi transceiver),connected to a corresponding antenna 902, for communicating with theSleeve or server.

The processor 908 has the capability to perform not only the radiocommunication services necessary to allow for phone and datacommunications (e.g., via the transceivers 901 and/or 902), but also toexecute various application programs that are stored in the memory 905.These application programs can receive inputs from the user via thedisplay 906 and/or keypad 907. In some embodiments, application programsstored in the memory 905 and run on the processor 908 are, for example,iPhone, Android, Windows Mobile, BREW, J2ME, or other mobileapplications and can encompass a broad array of application types.Examples of these applications include medical applications games, andmultimedia applications. Medical applications can include the Sleeve'sdecision support software package to assist the medical examiner duringheart auscultation to distinguish between normal/physiological andpathological heart murmurs by recording the acoustic signal of the heartand the ECG signal and analyze these signals.

Referring to FIG. 8, the mobile device 801 displays the acoustic heartsound 803 and/or ECG signals 802 on the mobile device while recordedfrom the Sleeve. It captures, displays, and uploads patient informationand the recorded signals to the backend server (encrypted). The mobiledevice displays heart sound analysis findings on the mobile device(in-time) or possible error messages generated by the back-endprocessing unit. It retrieves and display patient information from theback-end server on the mobile device. The user also saves and archivespatient data, heart sound and/or ECG recordings on a back-end server(secure and encrypted), using the mobile device.

FIG. 7 shows the interaction between the devices. For purposes of thisdisclosure, local computer 702 and mobile device 704 are defined toinclude all computing devices, whether portable or stationary. Thisdefinition includes, but is not limited to, electronic books, laptop andhandheld computers, cellular phones, pagers, desktop computers, personaldigital assistant (PDA), telehealth gateway or hub and wearablecomputers. The Sleeve 703 interconnects with the remote health server701. The Sleeve 703 may communicate with web applications running on theremote server 701 via the Internet or a private network 708. The Sleevemay include cellular, WiFi other wireless or wired communicationcapability so as to interconnect with the server 701 either continuouslyor periodically. Communication with the remote server 701 may be via thelocal computer 702 or mobile device 704. The Sleeve 703 may also includesome type of memory chip or memory module that may be removed andinserted into the local computer 702 or the mobile device 044 fortransfer of data. The Sleeve 703 may communicate with local computer 702by interconnecting a wire between the computer 702 and the Sleeve 703,or by “docking” the Sleeve 703 into a communications dock associatedwith computer 702. The Sleeve 704 may also communicate with the computer702 and a mobile device 74 by wireless communication 706, 705, such asinfrared communication, Bluetooth and Zigbee or with a wired connectionsuch as USB (Universal Serial Bus). The computer 702 and mobile device704 communicates with the remote server 701 by cellular, WiFi otherwireless or wired communications.

Referring to FIG. 15, in another embodiment, the circumference of thesleeve 1505 contains at least one microphone 1502 (e.g., electret,Micro-electromechanical systems (MEMS) or micro or piezoelectrictransducer capable of low frequency response applied to body surface)used to record a body sounds. The circumference of the sleeve alsocontains a temperature sensor to record body temperature 1504, and anaccelerometer 1503. In many embodiments, the accelerometer comprises atleast one of a piezoelectric accelerometer, capacitive accelerometer orelectromechanical accelerometer. The accelerometer 1503 may comprise a3-axis accelerometer to measure at least one of an inclination, aposition, an orientation or acceleration of the patient in threedimensions. Accelerometer can be used to provide respiration rate andblood flow for the patient. The above sensors have electrical leadsattached to them, running along the body of the sleeve, coming togetherto form at least one electrical connector 1403, 1405 in FIG. 14. Anypolymer or metal capable of being formed into a light weight, flexiblesheet is suitable for the sleeve sensor. The preferred materials arepolyolefin and silicon rubber. Useful polyolefins include polyethylene,polypropylene, polyvinyl chloride, and copolymers thereof. The sensorsleeve can also be made out of any other flexible and stretchablematerials or a combination of flexible and rigid materials. The ECGelectrodes are pieces of conductive material.

Referring to FIG. 10, the user selects a new session, 1000 and creates1001 or selects 1002 new patients using the custom software running onthe client device. New patients are created by entering patientinformation such as Name, patient ID, Birth Date, Gender, Weight,Contact details, Session, Systolic blood pressure, Diastolic bloodpressure and Height (this list is not intended to be exhaustive). Once apatient is selected user can start recording heart sound and or ECG1003. After recording, the results can be displayed 1004 to the user.User can go back to the main menu 1005 for recording option or reviewresults.

FIG. 13 also teaches the aspect of creating a patient 1301, by enteringpatient information or details 1302, using a client device. Patientdetails are uploaded to patient database 108 in FIG. 1 at the backendserver 113 in FIG. 1. Once patient details are uploaded, the patient isactivated for selection 1304.

Referring to FIG. 11, the user goes to the process of recording 1001physiological parameters (such as heart sound and/or ECG) by selectingor creating a patient. For heart sound, once a patient is selected, userselects auscultation location 1102 (Tricuspid, Aortic, Pulmonary,Apex(mitral)). User chooses patient posture by selecting Sitting,Standing or Supine. User also sets recording duration (e.g., 10 to 30seconds). Then, user records at least hearts sounds and ECG 1003. Inthis case, the user is a health care worker or physician. Continuousstreaming heart sounds and or ECG from the Sleeve (Bluetooth) is enabledwhen user taps onto the auscultation spot 804 in FIG. 8 (Aortic,Pulmonary, Tricuspid and Mitral), illustrated by a chest on theapplication, and initiate the recording for that particular position.The user can tap on the same position to discard the recording. Resultsare uploaded to server for analysis 1104. After analysis, results areavailable 1105 and transmitted to the client device.

Referring to FIG. 12, the user selects view a recording session 1201 byselecting a patient 1202, selects a location 1203 and retrieve the dataor recorded results 1204. Results are output on headphones or speakerswith sound quality Playback 1205 controls such as Start, Stop, Pause andVolume. For ECGs, distance measurements between two points inmilliseconds can be calculated such as Q-T intervals, using on-screencaliper tools. At this point, user can go back to the main menu or 1206or re-record 1208 or replace the recording 1207.

In yet another embodiment, FIG. 16 refers to the sensor sleeve 1602,attached to a processing module (referred to as enclosure box (EB))1601. The EB contains electronics circuitry that comprises a processorand the corresponding circuitries for biosensor parameters similar toFIG. 5. The Sleeve 1202 is attached to the EB 1601 via an electricalconnector 1603. The connector can be standard or micro Universal SerialBus (USB). The standard USB can be a 2.0 Standard-A type of USB plug, aflattened rectangle which inserts into a “downstream-port” receptacle onthe USB host that carries both power and data.

FIG. 17 shows the steps for measuring systolic performance index.Myocardial performance index (MPI) (Tei index) has been regarded as animportant parameter in the evaluation of ventricular systolic functionin congestive heart failure. MPI is defined as the sum of isovolumicrelaxation time (IVRT) and isovolumic contraction time (IVCT) divided byleft ventricular ejection time (LVET) ([IVRT+IVCT]/LVET). Systolicperformance index (SPI) is the isovolumic or isovolumetric contractiontime (the time period between the R peak of the ECG and the first heartsound—S1) divided by ejection period (the time period between the firstand second heart sound, S1-S2). Heart sound and ECG are acquired 140 andsynchronized 141 by the front-end recorder device (FIG. 1, 100). Fromthere, an algorithm running either on the recorder device (FIG. 1, 100),or the mobile device (FIG. 19, 131 OR FIG. 1, 106) or server device(FIG. 1, 113 OR FIG. 19, item 134) measures the isovolumic contraction142, shown in FIG. 18 item 150. Isovolumetric contraction occurs inearly systole, during which the ventricles contract with nocorresponding volume change, while contraction causes ventricularpressures to rise sharply. The isovolumetric contraction lasts onaverage about 0.03 s, but this short period of time is enough to buildup a sufficiently high pressure that eventually overcomes that of theaorta and the pulmonary trunk upon opening of the semilunar valves,therefore allowing the correct unidirectional flow of blood. Theejection period is also measured 144, which is time period between thefirst and second heart sound (S1 and S2) FIG. 18, item 151. Isovolumicrelaxation time (IVRT) is measure as well 143, an interval in thecardiac cycle, from the aortic component of the second heart sound, thatis, closure of the aortic valve, to onset of filling by opening of themitral valve FIG. 18 item 152 (the time between S2 and the outset of theT wave). A determination is made as to whether or not those parametersare within range (147-149), after which myocardial 150 and systolicperformance 151 indices are determined. MPI is measured when the systemdetects that the user is in sedentary position.

The ejection fraction (EF) is an important measurement in determininghow well your heart is pumping out blood and in diagnosing and trackingheart failure. A significant proportion of patients with heart failurehappen to have a normal ventricular ejection fraction atechocardiography during examination. Previously called diastolic heartfailure, it is nowadays referred to as heart failure with normalejection fraction (HFNEF) or HF with preserved ejection fraction. EFmeasures how much blood the left ventricle pumps out with eachcontraction. A normal heart's ejection fraction may be between 55 and70%. An ejection fraction of 60% means that 60% of the total amount ofblood in the left ventricle is pushed out with each heartbeat.

Systolic performance index (SPI) was found to have a significant inversecorrelation with the value of Left Ventricular Ejection Fraction (LVEF(r=−0.947; P<0.001)), and a significant positive correlation could beseen with the value of Myocardial Performance Index (MPI (r=0.796;P<0.001)). The sensitivity and specificity of SPI value 0.66 forpredicting an LVEF value 55% were found to be 100% and 90.9%,respectively, but the positive and inverse predictive values were 91.3%and 100%, respectively (Yilmaz et al. 2007). SPI is measured when thesystem detects that the user is in a sedentary position.

Other parameters such as third and fourth heart sounds, and the timethat it takes the left ventricular to gather enough to close the mitralvalve can be obtained (time period between the start of the QRS complexof the ECG to the first heart sound (S1), when the system detects thatthe user is in sedentary position.

The cardiac cycle FIG. 18 is a period from the beginning of one heartbeat to the beginning of the next one. It shows the relationship betweenthe heart's mechanical (phonocardiogram or heart sounds) 154, electrical(ECG) 155, volume 156 and pressure parameters. It consists of two parts:

1. Ventricular contraction called systole.2. Ventricular relaxation called diastole.Each part of the cardiac cycle consists of several phases characterizedby either a strong pressure change with constant volume or a volumechange with a relatively small change in pressure.

Systole includes:

1. Isovolumic contraction time (IVCT) 150.

2. Ejection Time (ET) 151.

Diastole includes:3. Isovolumic relaxation time (IVRT 152.4. Rapid ventricular filling.5. Slow ventricular filling (diastasis).6. Atrial contraction 153.

The duration of the cardiac cycle is inversely proportional to the heartrate. The cardiac cycle duration increases with a decrease in the heartrate and on the other it shortens with increasing heart rate. At anormal heart rate of 75 beats per minute, one cardiac cycle lasts 0.8second. Under resting conditions, systole occupies ⅓ and diastole ⅔ ofthe cardiac cycle duration. At an increasing heart rate (e.g. during anintensive muscle work), the duration of diastole decreases much morethan the duration of systole 154.

Arrhythmia Detection: To identify the ST-segment in an ECG signal,accurate detection of the isoelectric line, the J point and the heartrate are required. The isoelectric line is the baseline of theelectrocardiogram, typically measured between the T wave offset and thepreceding P wave onset. It indicates no muscular activity in the heartat a particular point of time. This is used as a reference to measureST-segment deviation. The J point is the inflection point at which theQRS complex changes its direction of propagation. It occurs after theoffset of the QRS point within a window of 20-50 samples at the rate of250 Hz of sampling. Our recognition algorithm involves applying threemajor functions; Discrete Wavelet Transformation (DWT), WindowingTechnique, and Slope Detection; on each ECG cycle 155.

With regard to arrhythmia (cardiac rhythm abnormalities) detection, thesystem is implemented by the Support Vector Machine (SVM) approach. Itis a supervised learning framework which performs classification byconstructing an N dimensional hyper-plane that optimally separates thedata into two categories (S. R. Gunn, “Support Vector Machines forClassification and Regression,” Technical Report, Dept. of Electronicsand Computer Science, University of Southampton, 1998). It is one of thebest learning algorithms that gives the flexibility for the choice ofthe kernel and performs training in less time when compared to otherlearning algorithms like neural networks. Every heart beat isrepresented as a row in the data set with its feature values and itsclass label. SVM aims to find the optimal separating plane and the datapoints that determine the position and the orientation of the plane arecalled the support vectors.

The system was designed to classify six major arrhythmia most commonlyobserved by the cardiologists. The classes include Normal (N), PrematureVentricular Contraction (V), Premature Atrial Contraction (A), Fusion(F), Right Bundle Branch Block (R), and Left Bundle Branch Block (L). Weuse two types of features to describe each heart beat or one cardiaccycle, i.e. Morphological Features, an DWT Features.

The system uses 12 morphological features, which give the timing, area,energy and correlation information of the signal. The system uses theST-segment features such as the slope of the ST segment, theST-deviation measurement and the correlation coefficients of the signalwith templates of each class. Each class is represented by a templatemanually chosen from the MIT-BIH database (MIT-BIH Arrhythmia Database.www.physionet.org/physiobank/) The correlation coefficient lies between0 and 1; the higher the coefficient is, the more likely it is for thesignal to belong to that class.

Twelve morphological features are being used. They are: (i) QS Width,(ii) Pre RR Interval, (iii) Post RR Interval, (iv) QR Width, (v) RSWidth, (vi) Mean Power Spectral Density, (vii) Area Under QR, (viii)Area Under RS, (ix) Autocorrelation Value, (x) ST-segment Deviation,(xi) Slope of ST, (xii) Correlation coefficient with class template. Thesystem uses 191 DWT (Discrete Wavelet Transform) coefficients, which areobtained by a 4 level decomposition of the signal with the db2 motherwavelet. These coefficients are based on the 180 samples taken torepresent each heartbeat. Six classifiers are trained, each foridentifying one arrhythmia type and using all the heart beats in thedatabank for training and testing. The six single beat classifiers are:Normal (N) vs. All, Ventricular Contraction (V) vs. All, PrematureAtrial Contraction (A) vs. All, Left Bundle Branch Block (L) vs. All,Right Bundle Branch Block (R) vs. All and Fusion (F) vs. All.

Each data sample (heart beat) is represented by its class label and all191+12=203 feature values, including the morphological and DWT features.Since we perform five-fold cross validation experiments, we use fourfolds of the data for training the classification system. In particular,we train six classifiers, one for identifying a particular type of beatusing the one-versus-all scheme, resulting in six binary beatclassifiers. After training, the test data set from the remaining fold(i.e., the fold not used for training) is given to the classificationsystem.

The classification is a two stage process. During the first stage, thetraining data is generated with the features selected. We have dividedthe ECG beats into five sets of equal number of beats. One out of thefive sets is randomly selected and labeled as Test Data Set. Theremaining four sets are labeled as Training Data Sets and are passedinto the feature extraction module where each beat is represented withthe 203 features. The sets thus obtained are used to train the learningalgorithm, SVM, which results in a SVM model file containing all thebeats which form the hyper plane for classification. In the secondstage, the SVM model file and the Test Data Set are given as the inputto the SVM classifier tuned to the selected parameters. The output ofthe classifier gives the prediction of the class for each beat in theTest Data Set.

In another embodiment, the front-end stethoscope recorder device (FIG.1, 100) is mounted on the wall, as part of an integrated point-of-carediagnostic system (IPCDS), FIG. 19, 129. The IPCDS 129 consists ofdiagnostic devices 130 which include the stethoscope recorder device(FIG. 1, 100), a blood pressure monitor, a spirometer, a pulse oximetry,a thermometer, a handheld ultrasound machine, a blood glucose meter, anotoscope and an ophthalmoscope. The diagnostic devices 130 collect datafrom a user or patient. The data collected includes blood oxygensaturation (SpO2%), heart rate, core body temperature, systolic anddiagnostic blood pressure, ECG, heart sound, ultra sound imaging heartmurmur and heart failure indication. The data from the diagnosticdevices is then transferred to a mobile device 131, such as smartphonesand tablets (also FIG. 1, 106) running mobile operating systems such asiOS (Apple) or Android (Google) or Windows (Microsoft), for display andinitial analysis via wireless communication, such as infraredcommunication, Bluetooth and Zigbee or with a wired connection such asUSB (Universal Serial Bus) 132. The mobile device 131 can be one of anelectronic book, laptop or handheld computer, cellular phone, personaldigital assistant (PDA), telehealth gateway or hub and wearablecomputers. The data is ultimately transferred to a health managementserver 134 (also FIG. 1, 113) via the Internet, cellular or a privatenetwork 133. Other patient medical devices can also collect and transferthe data to the health management server 134 (also FIG. 1, 113). Theseother patient medical devices include a. pacemaker, a holter monitor, ablood alcohol monitor, an alcohol Breathalyzer, an alcohol ignitioninterlock, a respiration monitor, an accelerometer, a skin galvanometer,a thermometer, a patient geo-location device, a scale, an intravenousflow regulator, patient height measuring device, a biochip assay device,a sphygmomanometer, a hazardous chemical agent monitor; an ionizingradiation sensor; a monitor for biological agents, a loop recorder, aspirometer, an event monitor, a prothrombin time (PT) monitor, aninternational normalized ratio (INR) monitor, a tremor sensor, adefibrillator, or any other medical device.

The management server FIG. 19, 134 (also FIG. 1, 113) includesprocessor(s) and memory storing instructions (software programs) beingexecuted the processor(s) to analyze and score data collected from thediagnostic devices and the other medical devices. The analysis includesthe detection of heart murmur, arrhythmia and hear failure. The softwareprograms analyze data received from the diagnostic devices and sendnotification of data trends that fall below a pre-established thresholdto client devices 135 (also FIG. 16, 1605), care providers 136 and toother stake holder client devices 137 such loved ones and family membersvia the Internet, cellular or a private network. In an alternativeembodiment, the IPCDS can be mounted on a mobile cart.

The IPCDS FIG. 19, 129 includes an electrical plug (not shown) and fiveelectrical outlets mounted on the IPCDS. The electrical plug connects toa conventional wall outlet for supplying electrical power to the mobiledevice 131 and the diagnostic medical devices 130. In anotherembodiment, the IPCDS includes a power supply for supplying power to thediagnostic medical devices. A structure supports the power supply (e.g.,battery or electrical generator), which may be mounted on the IPCDS.

What is claimed is:
 1. A method of determining and using a mechanicaland electrical footprint of the heart comprising: a. Acquiring anelectrical of the heart; b. Acquiring a mechanical footprint of theheart; c. Synchronizing the mechanical and electrical footprints of theheart; d. Determining via a processor normal and a pathological heartsounds the mechanical footprint of the heart, normal and abnormal heartrhythm from the electrical footprints of the heart; e. Determining viathe processor a time period between R peak of the electrical footprintof the heart and a first heart sound; f. Determining via the processor atime period the first and second heart sound of the mechanical footprintof the heart; g. Calculating systolic performance index (SPI) from thetime period between R peak of the electrical footprint of the heart andthe first heart sound, and the time period the first and second heartsound of the mechanical footprint of the heart; h. Correlating leftventricular ejection fraction parameter from the SPI calculation.
 2. Themethod according to claim 1, further comprising of determining the timeperiod between aortic component of a second heart sound to onset offilling by opening of a mitral valve.
 3. The method according to claim 1wherein the heart's electrical and mechanical footprints are transmittedto a mobile device.
 4. The method according to claim 1 whereinelectrical footprint of the heart is electrocardiogram (ECG).
 5. Themethod according to claim 1 wherein the acquisition of the ECG andphonocardiogram are from a front-end recorder that attaches to astethoscope.
 6. The method according to claim 1 wherein mechanicalfootprint further includes the acquisition of blood oxygen saturation.7. A system for determining and using a mechanical and electricalfootprint of the heart comprising: a. A front-end recorder device thatcontains a processor, memory storing instructions being executed by theprocessor to perform the following: b. Acquiring an electrical of theheart; c. Acquiring a mechanical footprint of the heart; d.Synchronizing the mechanical and electrical footprints of the heart; e.Determining normal and pathological heart sounds from mechanicalfootprint of the heart, normal and abnormal heart rhythm; f. Determininga time period between R peak of the electrical footprint of the heartand the first heart sound; g. Determining a time period the first andsecond heart sound of the mechanical footprint; h. Calculating systolicperformance index (SPI) from the time period between R peak of theelectrical footprint of the heart and the first heart sound, and thetime period the first and second heart sound of the mechanical footprintof the heart; i. Correlating left ventricular ejection fractionparameter from the SPI calculation.
 8. The system according to claim 7,further comprising of determining the time period between aorticcomponent of a second heart sound to onset of filling by opening of amitral valve.
 9. The system according to claim 7, wherein the myocardialperformance index is derived.
 10. The system according to claim 7wherein the heart's electrical and mechanical footprints are transmittedto a mobile device.